Implantable medical devices for extended release of therapeutic agents
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Publication Number
US-11478430-B2
Publication Date
2022-10-25
Expiration Date
Abstract
The invention pertains to implantable medical devices for controlled delivery of therapeutic agents. Some devices according to the invention have a titanium reservoir, and a porous titanium oxide based membrane to control the rate of release of the therapeutic agent. The reservoir contains a formulation of the active agent, including a stabilizer for the active agent, wherein the stabilizer is provided in an extended release configuration.
Core Innovation
The invention relates to an implantable drug delivery system that includes a metal capsule suitable for implantation and a reservoir encapsulated by the capsule. At least one nanoporous membrane is provided in fluid contact with the reservoir, and the reservoir contains a pharmaceutical composition including a water soluble therapeutic agent with an equilibrium solubility at room temperature of more than 1.0×10−3 M.
The system further includes at least one stability enhancing agent having a maximum solubility of 5% w/v or less. The stability enhancing agent is selected from a low-solubility base, a low-solubility surfactant, a low-solubility antioxidant, a low-solubility free radical scavenger, or a combination thereof, and the arrangement maintains long-term stability for therapeutic agents in an extended release configuration.
Nanoporous membrane-based diffusion pathways allow controlled therapeutic-agent release while the stability enhancing agent supports stabilization by maintaining a preferred microenvironment, including microenvironment pH maintenance. The stability-enhancing components include acidic polymers such as PLGA, low-solubility acids/bases, antioxidants and free radical scavengers, and embodiments include forced-degradation testing using nanotube membrane devices to assess therapeutic-agent purity over time.
Claims Coverage
The document provides two independent claims: an implantable drug delivery system claim and a method for treating a disease using the implantable drug delivery system. Across these claims, three inventive features are emphasized: the metal capsule-based implantable system with nanoporous membrane and reservoir, the water soluble therapeutic agent defined by an equilibrium solubility threshold, and the stability enhancing agent defined by a maximum solubility threshold and restricted to specific low-solubility categories.
Implantable metal capsule with nanoporous membrane in fluid contact with a reservoir
The implantable drug delivery system comprises a metal capsule suitable for implantation and a reservoir encapsulated by the capsule, wherein at least one nanoporous membrane is in fluid contact with the reservoir.
Water soluble therapeutic agent with defined equilibrium solubility
The reservoir contains a pharmaceutical composition including a water soluble therapeutic agent with an equilibrium solubility at room temperature of more than 1.0×10−3 M.
Stability enhancing agent with maximum solubility and limited low-solubility selection
The implantable drug delivery system includes at least one stability enhancing agent having a maximum solubility of 5% w/v or less, selected from a low-solubility base, a low-solubility surfactant, a low-solubility antioxidant, a low-solubility free radical scavenger, or a combination thereof.
Disease treatment by administering therapeutically effective amount using the defined implantable system
A method for treating a disease in a subject includes administering a therapeutically effective amount of a water soluble therapeutic agent with an equilibrium solubility at room temperature of more than 1.0×10−3 M contained within an implantable drug delivery system that includes a metal capsule suitable for implantation and at least one stability enhancing agent.
Stability enhancing agent in the method with maximum solubility and limited low-solubility selection
The at least one stability enhancing agent has a maximum solubility of 5% w/v or less and is selected from a low-solubility base, a low-solubility surfactant, a low-solubility antioxidant, a low-solubility free radical scavenger, or a combination thereof.
Both independent claims consistently require the same core configuration: a metal capsule-based implantable system with a reservoir and nanoporous membrane, together with a water soluble therapeutic agent defined by an equilibrium solubility threshold and a stability enhancing agent defined by a maximum solubility threshold and restricted to specific low-solubility categories. The method claim uses this system to treat disease by administering a therapeutically effective amount of the defined therapeutic agent.
Stated Advantages
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